MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G158

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Failure to Read Input Signal (1581); Under-Sensing (1661); Low impedance (2285); High Capture Threshold (3266)

Patient Problems Fall (1848); Malaise (2359); Insufficient Information (4580)

Event Date 05/01/2023

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited loss of capture (loc) and high capture thresholds on the right ventricular (rv) and left ventricular (lv) channels.The lv lead is a non-boston scientific product.It was noted that the capture on the right atrial (ra) channel was also in question.The ra channel also exhibited farfield oversensing of the ventricle signals.The ra channel exhibited a drop in amplitude and intermittent undersensing, as well.Additionally, the rv and ra channels' impedances have been gradually increasing but remain within range.The lv channel exhibited gradually decreasing impedance but also remain within range.It was noted that the pacing impedances on all three channels have been changing over the past 3 to 4 weeks.It was noted that the patient's respiratory rate had decreased around the same time.Additionally, this patient fell and was feeling poorly for a couple of weeks.It was noted that the patient was having a metabolic crisis around this time.The device remains in use.No adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17265945
• MDR Text Key: 318654809
• Report Number: 2124215-2023-35292
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2017
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 140856
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Female